Lanzotred soft capsules (Enzalutamide Soft capsules 40 mg)

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ENZALUTAMIDE

Available from:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (International Name):

ENZALUTAMIDE

Units in package:

28 x 4 Capsules

Manufactured by:

Lotus Pharmaceutical Co., Ltd. Nantou Plant

Patient Information leaflet

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LANZOTRED SOFT CAPSULES (ENZALUTAMIDE SOFT CAPSULES
40 MG)
Enzalutamide (40mg)
WHAT IS IN THIS LEAFLET
1.
What
_Lanzotred_
_ _
is used for
2.
How
_Lanzotred_
works
_3._
_ _
Before you use
_Lanzotred _
_4._
_ _
How to use
_Lanzotred _
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of
_Lanzotred _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _LANZOTRED_
_ _
IS USED FOR
Lanzotred
contains
the
active
substance enzalutamide. Lanzotred
is
used to treat adult men with prostate
cancer that:
-
No longer responds to a hormone
therapy or surgical treatment to lower
testosterone
Or
-
Has spread to other parts of the body
and responds to a hormone therapy or
surgical treatment to lower
testosterone.
HOW _LANZOTRED_
WORKS
Lanzotred
is a medicine that works
by blocking the activity of hormones
called androgens (such as
testosterone). By blocking androgens,
enzalutamide stops prostate cancer
cells from growing and dividing.
BEFORE YOU USE _LANZOTRED _
_When you must not use it _
•
If you are allergic to enzalutamide
or any of the other ingredients of
this medicine listed in section
‘
_Ingredients’. _
•
If you are pregnant or may become
pregnant (see ‘
_Pregnancy, breast- _
_feeding and fertility’_
)
_Before you start use it _
Warnings and precautions
Seizure
Seizures were reported people taking
Lanzotred (see ‘
_Taking other _
_medicines_
’ in this section and section
‘
_Side effects_
’).
If you are taking a medicine that can
cause seizures or that can increase the
susceptibility for having seizures (see
‘
_Taking other medicines_
’)
If you have a seizure during treatment:
See your doctor as soon as possible.
Your doctor may decide that you
should stop taking Lanzotred.
Posterior Reversible Encephalopathy
Syndrome (PRES)
There have been rare reports of PRES,
a rare, reversible condition involving
the brain, in patients treated with
Lanzotred. If you have a seizure,
worsening he

Summary of Product characteristics

Page 1 of 13
LANZOTRED SOFT CAPSULES
ENZALUTAMIDE SOFT CAPSULES 40 MG
COMPOSITION
Each capsule contains: Enzalutamide----------40 mg
Source of Gelatin: PORCINE
THERAPEUTIC INDICATIONS
Lanzotred is indicated for:
- the treatment of adult men with metastatic hormone-sensitive
prostate cancer (mHSPC) in
combination with androgen deprivation therapy (ADT).
- the treatment of adult men with high-risk non-metastatic
castration-resistant prostate cancer
(CRPC).
- the treatment of adult men with metastatic CRPC who are asymptomatic
or mildly
symptomatic after failure of androgen deprivation therapy in whom
chemotherapy is not yet
clinically indicated.
- the treatment of adult men with metastatic CRPC whose disease has
progressed on or after
docetaxel therapy.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 160 mg enzalutamide (four 40 mg capsules) as a
single oral daily
dose.
Medical castration with an LHRH analogue should be continued during
treatment of patients
not surgically castrated.
If a patient misses taking Lanzotred at the usual time, the prescribed
dose should be taken as
close as possible to the usual time. If a patient misses a dose for a
whole day, treatment should
be resumed the following day with the usual daily dose.
If a patient experiences a ≥ Grade 3 toxicity or an intolerable
adverse reaction, dosing should
be withheld for one week or until symptoms improve to ≤ Grade 2,
then resumed at the same
or a reduced dose (120 mg or 80 mg) if warranted.
_Concomitant use with strong CYP2C8 inhibitors _
The concomitant use of strong CYP2C8 inhibitors should be avoided if
possible. If patients
must be co- administered a strong CYP2C8 inhibitor, the dose of
enzalutamide should be
reduced to 80 mg once daily. If co-administration of the strong CYP2C8
inhibitor is
Page 2 of 13
discontinued, the enzalutamide dose should be returned to the dose
used prior to initiation of
the strong CYP2C8 inhibitor.
_Elderly _
No dose adjustment is necessary for elderly patients.
_Hepatic impairment _
No d